Pure Global AI
Medical Device Division · registration 180208Active

GE

Hong KongScanning Systems, Ultrasonic, CardiacClass IIGE Medical Systems (China) Co., Ltd.
Official record identity
MDACS listing number
180208
Model name
Vivid iq (Vivid iq v208), L4-20t-RS (H48062AJ), E8Cs-RS (H48062AF), Software Options (Pre-Post Compare, Advanced Contrast, Vascular Contrast, Probe Check, 4DAutoAVQ, 4DAutoLVQ, 4DAutoMVQ, 4D marker, LVOContrast, Smart stress, ICEProbeInterfaceModule, CartoSound interface, HD Color, AutoEF 3.0, Easy Auto EF, AFI 3.0, Easy AFI LV, DICOM Viewer, AdvQScan(TSI, SI, SRI), LOGIQ View, AFI RV, AFI LA, AI Auto Measure – 2D, AI Auto Measure - Spectrum Recognition, Streaming (alton HCAT), Enable M5Sc probe, Remote Viewing, Clarity+ (Advanced SRI))
Registration date
September 26, 2025
Expiry date
June 21, 2028
Status
Active
Official value: Valid
Classification
Risk class
Class II
Official value: II
Published category
Scanning Systems, Ultrasonic, Cardiac
Published parties
Registrant / registration holder
GE Medical Systems Hong Kong Limited
Official description

Scanning Systems, Ultrasonic, Cardiac

Additional source fields
AMD nomenclature code
17422
Local responsible person phone
21006300
Published manufacturer address
No. 19, Changjiang Road, Wuxi National Hi-Tech Dev.Zone, 214028 Jiangsu, China
Revision number
c
About this record

This page mirrors one official MDACS listing. Roman-numeral classes use Hong Kong’s general medical-device scheme, while letter classes use the IVD scheme. Valid, expired, and delisted records remain distinguishable; no mixed classification scale is fabricated.